clinical trials

Scientists have made enormous strides in understanding how Alzheimer’s disease affects the brain. Many of these insights point toward new therapies and improved ways to diagnose the disease and monitor its progression.

At any given time, dozens of studies are recruiting participants to help explore these exciting new approaches. Every clinical study contributes valuable knowledge, regardless of whether the experimental strategy works as hoped.

Without study participants, however, progress is stalled, and scientists report growing difficulty finding enough volunteers to complete these studies.

If you or a friend or family member has Alzheimer’s or another dementia — or even if you don’t — you can help advance knowledge about this illness. By participating in a clinical study, you can help new treatments, preventive strategies and diagnostic tools to become a reality.

What is a clinical study?

A clinical study is any medical research project involving human volunteers. Research into improved approaches usually begins with laboratory work or animal studies. Following early success with these methods, new strategies must demonstrate their effectiveness in the final proving ground of human testing.

What is a clinical trial?

A clinical trial is a specific type of study in which one group of volunteers gets an experimental treatment, while a similar group gets a placebo ( a look-alike “sugar pill”). Scientists evaluate the effect of the new treatment by comparing outcomes in the two groups.

Phases of clinical trials

The U.S. Food and Drug Administration (FDA), which regulates medical products and drugs, oversees a rigorous process for testing experimental treatments that is based on sequential phases. The treatments must perform well enough in each phase to progress to the next one. If a treatment performs adequately in all stages through Phase III, the FDA reviews the data and determines  whether to approve the drug for use in general medical practice.

  • Phase 1 trials, the first stage of human testing, typically enroll fewer than 100 volunteers. These studies are primarily concerned with assessing the safety of a drug and whether it has risks or side effects.
  • Phase II trials enroll up to a few hundred volunteers with the condition the drug is designed to treat. These studies provide further information about the safety of the drug and focus on determining the best dosage. Scientists also watch for signs of effectiveness, but Phase II trials are generally too small to provide clear evidence about benefit.
  • Phase III trials may enroll several hundred to thousands of volunteers, often at multiple study sites nationwide or internationally. Phase III trials provide the chief evidence for safety and effectiveness that the FDA will consider when deciding whether to approve a new drug.
  • Phase IV trials, also called post-marketing studies, are often required by the FDA after a drug is approved. The trial sponsor must monitor the health of individuals taking the drug to gain further insight into its long-term safety effectiveness and the best way to use it.

How to find a study near you

Alzheimer’s Association TrialMatch is a clinical studies matching service. TrialMatch uses information about your diagnosis, location and preferences to match a person with current clinical studies. Finding the right trial can be done over the phone or online. Once a match is found, and with your permission, a TrialMatch specialist will contact you to answer questions.

If you would like to consider participating in a clinical study, call 1-800-272-3900 or visit alz.org/trialmatch. More information about clinical studies can also be found at clinicaltrials.gov.

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